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临床试验/NCT04162093
NCT04162093已完成不适用

Preliminary Report Following A Modified Uretero-Ileal Anastomosis in An Ileal Neobladder Combining Wallace Technique With an Extramural Subserous Tunnel in a Single Trough: Our Initial Short-term Results

Ain Shams University0 个研究点目标入组 45 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
主要终点
the rate of vesicoureteral reflux (VUR)

研究概览

简要总结

there are many techniques for uretero-ileal anastomosis some of them are antirefluxing for protection of the upper urinary tract with many complications including strictures and pyelonephritis with difficult technical issues and long operation time so a modified technique combining the 2 ureter by wallace technique and implanted them in a single trough in the neobladder making the surgery easier and shorter.

this technique was done after informed consent in 45 patients with muscle invasive bladder cancer candidate for radical cystectomy and ileal neobladder diversion

详细描述

This was a prospective study conducted from 2014 to 2017 in Ain shams university, 73 patients were enrolled from outpatient clinic diagnosed with muscle invasive bladder cancer and candidate for radical cystectomy and orthotopic urinary diversion, 45 patients were included according to patient's acceptance and the inclusion and exclusion criteria.

After having a written informed consent, all selected patients were assessed by detailed history and physical examination, contrast enhanced pelvi-abdominal Computed tomography (CT) scan (for patients with serum creatinine <1.5 mg/dl). Laboratory investigations in the form of complete blood count, coagulation profile, electrolytes, renal and liver function tests. Bowel preparation was done to all patients one or two days before operation.

Cases were diverted using a U-shaped pouch with uretero-ileal anastomosis done in a single trough combining the extramural serous-lined tunnel and Wallace techniques.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

the rate of vesicoureteral reflux (VUR)

时间窗: after 6 months and after one year

the incidence of occurrence of reflux in the patients was assessed

the post operative changes in the mean serum creatinine level

时间窗: after 6 months and after one year

the change in mean serum creatinine level of the patients was assessed

the incidence of anastomotic stricture

时间窗: after 6 months and after one year

the incidence of occurrence of uretero ileal stricture in the patients was recorded

次要结局

  • the incidence of urinary incontinence(after 6 months and after one year)
  • the incidence of pyelonephritis(after 6 months and after one year)
  • the mean operative time of urinary diversion(at the time of the operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Elawady

lecturer of urology

Ain Shams University

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